MedShape Announces FDA Clearance for the DynaNail® XL

ATLANTA, Nov. 14, 2017 /PRNewswire/ — MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the DynaNail® XL TTC Fusion System. The DynaNail XL is available in 260mm and 300mm lengths, thus expanding the product’s use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM) nail. The DynaNail XL will be launched in early 2018.

Indicated for tibiotalocalcaneal (TTC) fusion surgery, the DynaNail XL was developed in response to surgeon demand for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. Its longer length in combination with DynaNail’s pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.1 DynaNail XL features a similar design as the original 220 mm version but also has a proximal taper for easy insertion through the tibial isthmus and an extra proximal screw hole for an optional cortical screw for additional stability.

Clinically introduced in 2012, the DynaNail is the first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL to provide the compression performance of an external frame inside an IM nail design. Compression has shown to be important not only in keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing. Like the original 220mm version, the DynaNail XL features an internal NiTiNOL Compressive Element that maintains post-operative compression for up to 6 mm of bone resorption and settling. The DynaNail Compressive Element also allows for effective load sharing across the bone due to its axial compliance during weight-bearing.2 To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic.3,4,5

The FDA clearance of the DynaNail XL closes out a year noted by several updates to the DynaNail product line. In June, the DynaFrame™ Carbon-Fiber (CF) Deployment System was launched, providing surgeons with a simple, robust method to insert the DynaNail and activate the NiTiNOL element during surgery. This was followed by the release of new instrument sets to accommodate the increased demand. Finally, with the DynaNail XL, MedShape also gained clearance to offer a new alternate surgical technique that allows for a more streamlined approach and the option for automatic dynamization once the NiTiNOL Element has fully recovered.

“The recent additions to the DynaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product,” said Kurt Jacobus, MedShape CEO. “We have been pleased with the growing adoption of this unique technology by both orthopaedic surgeons and podiatrists and anticipate continued growth with these new offerings.”

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.medshape.com.